title: Observer and biological variation of a rapid whole blood D-dimer test.
abstract: In consecutive patients with suspected venous thromboembolism the interobserver variability of the SimpliRED D-dimer test was evaluated by two observers who independently scored one plate, the between assay variation was performed simultaneously by a third independent observer, who assessed a second plate. The biological variation was studied, 1-4 hours later by an independent evaluation. A total of 155 patients entered the study, venous thromboembolism was present in 42 patients (28%). The interobserver variability was 2/83 samples, with a kappa of 0.95 (95% confidence interval 0.88-1.0). The between assay variation was 2/98, with a kappa value of 0.96 (95% confidence interval 0.90-1.0). When testing the biological variation the observers disagreed in 2 of 69 patients (3%). The SimpliRED D-dimer assay has a good to excellent interobserver variability, between assay variation and reproducibility.
authors.affiliation: Academic Medical Center, University of Amsterdam, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Turkstra
authors.forename: E J
authors.initials: EJ
authors.lastname: van Beek
authors.forename: H R
authors.initials: HR
authors.lastname: Büller
mesh_terms: D000293:Adolescent; D000328:Adult; D016001:Confidence Intervals; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D008297:Male; D015588:Observer Variation; D011237:Predictive Value of Tests; D015995:Prevalence; D015203:Reproducibility of Results; D013923:Thromboembolism / Q000097:blood* / Q000175:diagnosis / Q000453:epidemiology; D013997:Time Factors
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D